Protocol for the isotoxic intensity modulated radiotherapy (IMRT) in stage III non-small cell lung cancer (NSCLC): a feasibility study

摘要: Introduction The majority of stage III patients with non-small cell lung cancer (NSCLC) are unsuitable for concurrent chemoradiotherapy, the non-surgical gold standard care. As alternative treatment options sequential chemoradiotherapy and radiotherapy alone associated high local failure rates, various intensification strategies have been employed. There is evidence to suggest that altered fractionation using hyperfractionation, acceleration, dose escalation, individualisation may be benefit. MAASTRO group pioneered concept ‘isotoxic’ allowing individualised escalation hyperfractionated accelerated based on predefined normal tissue constraints. This study aims evaluate whether delivering isotoxic intensity modulated (IMRT) achievable. Methods analysis Isotoxic IMRT a multicentre feasibility study. From June 2014, total 35 from 7 UK centres, proven histological or cytological diagnosis inoperable NSCLC, will recruited. A minimum 2 cycles induction chemotherapy mandated before starting radiotherapy. radiation increased until one more organs at risk tolerance maximum 79.2 Gy reached. primary end point feasibility, accrual control overall survival our secondary points. Patients followed up 5 years. Ethics dissemination has received ethical approval (REC reference: 13/NW/0480) National Research Service (NRES) Committee North West—Greater Manchester South. trial conducted in accordance Declaration Helsinki Good Clinical Practice (GCP). results published peer-reviewed journal presented internationally. Trial registration number NCT01836692; Pre-results.